Isosorbide Dinitrate

Product NDC
55154-7990
11-digit product format
551547990
Labeler code
55154
Product ID
55154-7990_dde61426-7d3b-40a3-9fd4-f654bfb75693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA086066
Marketing category
ANDA
Marketing start
1978-12-01
Substance
ISOSORBIDE DINITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide Dinitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui206842, 381056

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44Product name420230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9Product name120140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7990-0Isosorbide Dinitrate10 in 1 BAGTABLET1010
55154-7990-0Isosorbide Dinitrate1 in 1 BLISTER PACKTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7990ISOSORBIDE DINITRATE TABLET [CARDINAL HEALTH 107, LLC]8Current NDC, Legacy NDC, 2 package rows20250112_5f585259-59ed-4648-b562-164f3746c821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN5f585259-59ed-4648-b562-164f3746c82110
206842isosorbide dinitrate 20 MG Oral TabletPSN5f585259-59ed-4648-b562-164f3746c82110
381056isosorbide dinitrate 10 MG Oral TabletSCD5f585259-59ed-4648-b562-164f3746c82110
206842isosorbide dinitrate 20 MG Oral TabletSCD5f585259-59ed-4648-b562-164f3746c82110
381056ISDN 10 MG Oral TabletSY5f585259-59ed-4648-b562-164f3746c82110
206842ISDN 20 MG Oral TabletSY5f585259-59ed-4648-b562-164f3746c82110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7990-05515479900010 BLISTER PACK in 1 BAG (55154-7990-0) / 1 TABLET in 1 BLISTER PACK10 blister pack1978-12-010000-00-00NoNoCurrent